Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III (PAPAYA-III)

Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care (PAPAYA III) - A European Multicentre Cross-sectional Observational Study

The overall objective of the study is to evaluate and analyze major and minor incidents during airway management in adults under anaesthesia care at all study sites. The patient characteristics, type of airway management is recorded and if airway management-related incidents occur, they are analyzed in more detail to improve patient safety in the future.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Complication of Anesthesia; Adverse Events

Detailed Description

It is a prospective observational cross-sectional European multi-centre study collecting health-related patient data on anaesthetic airway management over three months. This detects the incidence and nature of local airway management problems and assesses how they are solved. This will enable the investigators to identify generalisable interventions and recommendations to further improve patients' airway management to improve patient safety. During the observational period, the anaesthesia staff in charge will fill out a screening questionnaire for airway management for every patient undergoing anaesthesia care with airway management. The investigators will extract the characteristics from the local anaesthesia record system for all patients. If no event arises, there are no further requirements. If an event occurs, the anaesthesia provider will fill out an additional form asking for more details on what happened.

• Study Type: Observational
• Enrollment (Estimated): 40000

Contacts and Locations

• Study Contact: Name: Thomas Riva, MD,PD; Phone Number: +41 31 632 21 11; Email: thomas.riva@insel.ch
• Study Contact Backup: Name: Alexander Fuchs, MD; Phone Number: +41 31 664 14 65; Email: alexander.fuchs@insel.ch

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum der Charité and Charité
    • Contact: Maren Kleine-Bruggeney, Prof
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
    • Contact: Martina Petzoldt, PD
• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau
    • Contact: Lorenz Theiler, Prof
  • Lausanne, Switzerland, 1011
    • CHUV centre hospitalier universitaire vaudois
    • Contact: Patrick Schoettker, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All adult patients (<18 years of age) that undergo in-hospital airway management under anaesthesia care who do not object to the use of their data collected for the purpose of this study.

Description

Inclusion Criteria:

• All adult patients requiring airway management under anaesthesia care for elective, semi-elective, urgent or emergency diagnostic procedures or interventions. Airway management includes awake and asleep tracheal intubation, insertion of supraglottic airway devices, and face mask ventilation.
• Patients older than 18 years of age
• Informed consent given or general consent in place, according to local ethics committee requirements.

Exclusion Criteria:

• Refusal to give consent or withdrawal of consent.
• Patients <18 years.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of airway management related incidents	Primary study outcome is the number of anaesthesia cases with at least one airway management related incidents in adult patients under anaesthesia care.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidences of the individual major incidents	Secondary study outcome parameters are the incidences of the major critical events and the number of incidents per case incidents.	30 days
The Incidences of the individual minor incidents	Secondary study outcome parameters are the incidences of the minor critical events and the number of incidents per case incidents.	30 days

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Charite University, Berlin, Germany; Kantonsspital Aarau; University of Lausanne Hospitals; University of Bern; Universitätsklinikum Hamburg-Eppendorf
• Investigators: Study Chair: Robert Greif, MD, Prof, Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Difficult Airway; Anesthesiology; Intubation, Intratracheal; Critical events
• Other Study ID Numbers: PAPAYA III; 2023-01752 (Registry Identifier: Swissethics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No